Mouth-to-mouth resuscitation devices of the type having a one-way valve through which air is delivered from a resuscitator""s mouth to a victim""s mouth and lungs through the valve.
The effective use of mouth-to-mouth resuscitation devices often depends upon how easy it is for a user of the device to be trained in its use. Classes in cardiopulmonary resuscitation often include ordinary citizens with no paramedical background as well as individuals in training for positions as paramedics. Equipment available for training ranges from those rare settings in which anatomically correct mannequins are provided to practice pulmonary resuscitation, to those settings where a mannequin""s head resembles a human head and face only in that there is suggestion of facial feathers. The heads are normally formed of hard, hollow plastic. These suggested features usually include raised portions representative of a nose and forehead. Indentations may appear where eyes would be located and a small circular or oval opening is providing to simulate a mouth. More often than not the mannequin""s head size more nearly matches an average adult head rather than a child or infant. Among the most popular resuscitation masks in industrial and commercial settings are those that include a physical shield between a rescuer and a victim requiring mouth-to-mouth resuscitation. The shield frequently takes the form of a flexible sheet having a centrally formed opening and a rigid tube secured to the sheet around the periphery of the opening. The rigid tube is intended to fit within a victim""s mouth. The tube routinely includes a one-way valve to allow breath exhaled by the rescuer to pass through the tube/one-way valve and into the mouth and lungs of the victim. The one-way valve and shield act to prevent exhaled or regurgitated matter of the victim from entering the mouth of the rescuer.
Typical of such devices is that shown and described in Eisenberg et al. U.S. Pat. No. 4, 819, 628 (""628) issued Apr. 11, 1989, which shows and describes a device that includes a flexible sheet having an opening centrally formed therein and a rigid tube secured to the sheet around the periphery of the opening for insertion into a mouth of a victim. A self-closing one-way valve is contained in the tube and extends downward from the sheet opening.
A highly enhanced version of a resuscitation mask that also includes a flexible sheet with rigid tube located and secured into the flexible sheet in a similar fashion to the ""628 patent is applicant""s own double shield mouth-to-mouth resuscitator mask with a barrier for contaminated fingers, namely Baldwin U.S. Pat. No. 5,664,559 (""559) issued Sep. 9, 1997. This patent distinguishes over the ""628 patent in that there is provided a second flexible barrier in the form of a thin sheet of flexible material that has an opening the periphery of which is secured to a first flexible barrier and a rigid tube containing a one-way-valve to thereby provide a spatially separated region between the first and second barriers to thereby isolate the mouth and face of the operator from the area where the operator""s fingers/hands make contact on the first flexible barrier.
Another resuscitation mask of this type is shown and disclosed in applicant""s co-pending patent application Ser. No. 09/128,112, filed Aug. 3, 1998, titled Resuscitation Device with Instantly Closing Valve. A unique aspect of this invention resides in the employment of a flexible sleeve integrally secured to a flexible barrier sheet. At an outlet end of the flexible sleeve, the sleeve has fashioned therein a rigid member to create a one-way valve against the rigid member. The flexible sleeve is stretched to open the one-way valve when air is delivered to an inlet opening of the sleeve and then to and through the sleeve and past a flexible seal of the one-way valve. Positive, instant closing is provided when air is no longer delivered to the inset opening. The invention just described provides a resuscitation device free of a valve housing, thereby allowing the device to be folded into a flat configuration to be readily carried in a billfold, thus encouraging its use by laymen.
In training situations both instructor and trainee are faced with the reality that the rigid tube that is normally inserted into a victim""s mouth must now be inserted into the circular or oval mouth opening of the mannequin""s head. Rarely is the mannequin mouth opening of a size that adequately accommodates the rigid tube. It is not uncommon for the attempted application of the mask to the mannequin""s face to result in the rigid tube secured to the flexible barrier to buckle in the region where the tube joins the barrier. When this happens, the tube opening that is intended to engage the mannequin""s mouth opening topples onto its side, making it nearly impossible for the instructor or rescuer in training to place his/her mouth in the opposite side of the barrier and over the other end of the tube.
it is not surprising to find that instructors favor less effective resuscitation masks for certain kinds of mannequin""s that do not have any part thereof that enter the mouth when in use.
The subject invention avoids all these problems by recognizing that the rigid tube must be secured to the flexible barrier by a means that allows the rigid tube to remain perpendicular to the flexible barrier and/or mouth region of a mannequin or victim where the victim""s mouth can only be partially opened. The mask incorporating the subject invention not only provides a rigid tube covered by a sleeve portion of the flexible barrier that may engage a partially open mouth of a victim, while simultaneously converting to a mask with the rigid tube extending toward the victim""s face by the simple application of a force pressing on the tube toward the face of the victim as the mask is about to be placed on a victim""s face.
The invention is directed to a mouth-to-mouth, manually manipulated resuscitation mask, which includes a flexible barrier for providing a sealing contact with a face of a victim in a region adjacent to a mouth of a victim. The flexible barrier is comprised of a thermoplastic sheet having an opening therethrough to cooperate with a mouth of a victim. The opening in the sheet is comprised of an integrally connected, flexible sleeve, extending away from the flexible sheet and the victim""s face. The sleeve has an open end remote from where the sleeve is integrally connected to the flexible barrier sheet. The mask also includes a tubular member that has first and second end portions. The tubular member is positionable within the sleeve and has the first end portion integrally secured to the open end of the sleeve. The second end portion of the tubular member is located adjacent to the flexible barrier sheet when the tubular member is positioned within the sleeve. The sleeve and tubular member as just described are readily available to engage a mouth of a rescuer to deliver air from lungs and mouth of a rescuer to and through the tube to the mouth of a victim. Typically a one-way-valve and a filter or combinations thereof are fitted into the tubular member.
The tubular member is manually moveable such that the second end portion of the tubular member may extend through the flexible sheet to engage a mouth of a victim, while simultaneously allowing their lips to press against the flexible sheet to seal the sheet against the victim""s face.
The invention further contemplates the inclusion of a method to produce the manually manipulated resuscitation mask. In a preferred embodiment the method involves differential pressure forming a resuscitation mask of the type that may include a one-way valve and does include a thermoplastic flexible barrier sheet hermetically secured to a tubular member through which air is delivered from a rescuer""s mouth to a victim""s mouth and lungs.
The method is comprised of the following steps which include placing the tubular member in engagement with a porous plate such that a central axis of the tubular member is essentially perpendicular to the porous plate.
The next step involves locating the thermoplastic, flexible barrier sheet between the tubular member and a source of heat, followed by activating the source of heat to soften the thermoplastic flexible barrier sheet.
This step is succeeded by establishing a low-pressure region on a side of the porous plate opposite to the porous plate side on which the tubular member has engaged the porous plate. The low pressure region thereby causes a differential pressure across the porous plate that results in the softened thermoplastic flexible barrier sheet being drawn towards the tubular member and taking on a new shape, such that at least a portion of the tubular member becomes sandwiched between the softened flexible sheet and the porous plate.
The softened thermoplastic flexible barrier sheet is the cooled to thereby cause the flexible thermoplastic sheet to maintain it""s new shape. Thereafter an opening is created through the flexible sheet in a region where the surface of the flexible sheet is defined by the tubular member.
The final step involves inserting into the tubular member, through the opening in the flexible thermoplastic sheet, an insert. The insert mates with the flexible sheet to help secure the flexible sheet to the tubular member. It is therefor a primary object of this invention to provide a resuscitation mask which easily allows a user of the mask to adjust a victim""s mouth-engaging portion of the mask such that the mask may engage a face surface of a victim or physically enter an open mouth.
Another object of the invention is to provide an adjustable resuscitation mask that cooperates effectively with a wide variety of the mouth openings found in training mannequins.
Yet another object of this invention is to provide a simple differential pressure forming method for creating an adjustable resuscitation mask.